Related Pages Protecting Participants in Clinical Trials A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study. Protecting Human Research Participants A free, on-line tutorial offered by the National Institutes of Health (NIH) Office of Extramural Research, for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.

What Should I Expect During the Informed Consent Process?

According to The Belmont Report, the informed consent process relies on three principles:

• adequate information is provided (generally, what a "reasonable person" would want to know to make a decision);
  
  
• participants comprehend the information; and
  
  
• consent is given voluntarily.

While this process varies among different research institutions and clinical centers, you generally should expect the following:

• An initial meeting during which a member (or members) of the research team provides you with the informed consent document and explains its content to you. This discussion may also include your oncologist (cancer specialist) and primary care doctor, as well as a nurse, social worker, patient representative, and/or staff psychologist. You may wish to bring along a family member or friend for support, and to help you keep track of the information presented. This information should be given logically and at a comfortable pace, with plenty of time allowed for you to consider it and ask questions. You may be given a video, audiotape, or even an interactive computer program to help you better understand the information in the consent document.

If your child (under age 18) is the one who will participate in the clinical trial, you will go through this process on his or her behalf. More and more frequently, children over the age of 6 are being asked to give their "assent" to participation as well. If this is the case, you will be asked to give permission for your child to take part in the assent process. During this process, a child or teenager is provided with a form that explains, in concrete and age-appropriate terms, the purpose of the research, what they will be asked to do, and what procedures they will undergo. Usually, a nurse or other heath professional also explains the information and gives the child a chance to ask questions. Then they are asked to indicate their assent either by signing the form or making a mark in a specific place.

The following example gives you an idea of what a child participant assent form might look like:

• Time to digest the information. It can be very difficult to absorb this information in one sitting, especially at a time of emotional distress. You should be given a copy of the document so that that you can take it home, review it as many times as you need, and discuss it with family, friends, social workers, clergy, a patient representative, or other trusted advisors.
  
  
• Assessment of your understanding. The research team should take some steps to ensure that you comprehend the information, either by having you fill out a questionnaire, asking you questions orally, or having you explain certain aspects of the trial in your own words. You also should alert team members to anything you do not understand. If you find that the document is written in words that are too difficult for you, don't hesitate to let them know that.
  
  
• Opportunities to ask questions. Both during the initial meeting and in follow-up discussion(s), you should be given the chance to ask questions and raise concerns. Keep asking questions until you have all the information you need to make your decision.
  
  
• Continuing updates on new information. As the trial proceeds, the research team may discover new information that could affect your health, welfare, or willingness to remain in the study. They will share this with you and may ask you to sign a new informed consent document. Of course, you are free to leave the study if this information leads you to have doubts about continuing to participate.

What Will I Find in the Informed Consent Document?

In 1998 the National Cancer Institute Working Group on Informed Consent issued recommendations designed to help research institutions and clinical centers write comprehensive, user-friendly informed consent documents. The group also developed a template and sample forms that provide models for covering all of the information that federal regulations require for informed consent documents.

You may wish to print out the template or a sample form and use it as a model of what to look for in the document that you receive.

While informed consent documents do vary from place to place, they should communicate all of the information described below in language that you can understand, with some help from the research team (if needed). Even if your trial is not federally funded and therefore not governed by these regulations, you should know that any scientifically valid trial will provide an informed consent document that supplies such information

The information covered should include:

• TITLE
• PURPOSE [Why is this clinical trial being done?]

In this section, researchers explain why they are conducting the trial. Their reasons will depend on the type of cancer and the trial type (i.e., whether they are investigating new prevention, screening, supportive care, or treatment methods). Researchers conduct treatment trials either because they have not found an effective treatment for a certain type of cancer, or they are not sure which treatment method works best.

In these trials, Phase I tests the safety and effectiveness of a new treatment, or aims to find out what dosage of a new drug can be given safely. Phase II treatment trials evaluate the effects (good and bad) that a treatment may have on people with a certain type of cancer. Phase III treatment trials compare the effectiveness of a new treatment or treatment combination with that of standard treatment. Researchers use prevention, screening, and supportive care trials to evaluate new strategies for preventing cancer, detecting it more accurately and effectively, and alleviating treatment side effects.

• DESCRIPTION OF PROCEDURES [What is involved in the trial?]

This section describes the procedures that you will undergo, how frequently you will have them, and where they will take place (at home, in the hospital or clinical center, or in an outpatient setting). For treatment trials, this section should include:

• procedures that are part of regular cancer care and may be done even if you do not join the trial;
  
  
• standard procedures being done because you are in the trial; and
  
  
• procedures that are being tested or evaluated by the trial.

If this is a "randomized" trial, then you will be assigned at random (by computer) into one of two or more study groups. People in the different groups will receive different treatments or treatment combinations, so that researchers can evaluate which is most effective. If this is the case, the document should make clear what procedures each group will undergo. It should also indicate what your chances are of being placed in any one group.

• DURATION [How long will I be in the trial?]

This section indicates how long the trial will last and whether it involves followup, and if so, for how long. It also includes information about any circumstances under which the researcher might remove you from the trial (for example, if your condition worsens or new information indicates you shouldn't continue). The document should make clear that you have the right to stop participating at any time, and it should describe any possible medical consequences of sudden withdrawal.

• RISKS [What are the risks of the trial?]

This section includes the foreseeable physical and nonphysical risks of participating in the trial. A nonphysical risk might be time away from work, while physical risks might include side effects such as nausea, vomiting, pain, or susceptibility to infection, among others. The document should indicate the likelihood of these risks occurring, how serious they may be, and whether they are more likely to be short-term (last only during the trial or shortly afterward) or long-term (last weeks, months, or even years after the trial is over). The document should make clear which risks are related to the investigational aspects of the trial. It also should include specific information about reproductive risks (Could participating make you infertile? Should you not get pregnant or father a child while on the trial? Can you nurse a child during the trial?).

• BENEFITS [Are there benefits to taking part?]

The document describes any benefits to you or to others which may reasonably be expected. A trial may or may not involve direct medical benefits to you, but it might lead to new knowledge that can help others in the future.

• ALTERNATIVES TO PARTICIPATION [What are my options if I don't participate?]

For treatment trials, this section describes what care options you have besides participating in the trial, such as other commonly-used therapies or no treatment at all.

• CONFIDENTIALITY

This statement tells you the extent to which your information will be kept confidential. It should inform you about any groups or organizations that may have access to your records for quality assurance and data analysis (such as the National Cancer Institute, the Food and Drug Administration, or other trial sponsor).

• COSTS/ ADDITIONAL EXPENSES [What are the costs?]

This section indicates whether participating in the trial will result in added costs to you or your insurance company (see Clinical Trials and Insurance Coverage - A Resource Guide for more information on this topic). It also covers other cost issues, such as who will pay for emergency medical treatment in case of injury or illness, whether you will have to pay for drugs that become commercially available during the trial (if this is a drug trial), and whether or not you will receive payment for participating.

• PARTICIPANT'S RIGHTS [What are my rights as a participant?]

The document should specify that:

1. your participation is voluntary;
   
   
2. you can choose not to take part or leave at any time without penalty or loss of benefits; and
   
   
3. any new information that might affect your participation will be shared with you.

• CONTACT INFORMATION [Whom do I call if I have questions or problems?]

You should have a contact name and phone number (usually of a member of the research team) for getting answers to questions about the study or a research-related injury. You also should be given a phone number for the Institutional Review Board or a patient representative, in case you have questions about your rights as a research participant.

• SUPPLEMENTAL INFORMATION [Where can I get more information?]

This section lists additional resources that may prove useful as you make your decision, such as NCI's Cancer Information Service, informational booklets, community organizations, and Web resources.

• THE SIGNATURE

Your signature represents your legal consent to participate in the trial.

If any of these sections appears to be incomplete or missing from the informed consent document, don't hesitate to ask for the information.

Other Useful Tips

• Keep a copy of the informed consent document as a helpful resource for the duration of the trial. Ask for a copy if one isn't offered to you. You may also request a copy of the protocol (full study plan).
  
  
• According to Federal regulations, no informed consent document may include any language that asks or appears to ask you to waive your legal rights, or that releases or appears to release the investigator, the sponsor, or the institution from liability for negligence.
  
  
• If you cannot understand the forms you are signing, don't be afraid to let someone know that you are having trouble. If you have difficulties reading the document at first, try not to get upset. Many people feel anxious about reading and signing documents and communicating with physicians. Just take your time and ask for help when you need it.

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